Two Big Moves at FDA
From: Medical Device + Diagnostic Industry
FDA launched two major initiatives in 2016—cybersecurity requirements and a national system for real-world device monitoring.
Jim Dickinson
The last year of the Obama Administration will likely be remembered by FDA-watchers for two major agency initiatives affecting medical device regulation: cybersecurity requirements and CDRH’s establishment of a National Evaluation System for “real world” device monitoring, one of three strategic priorities for the 2016-2017 timeframe.
Each of these has been under congressional scrutiny, something that both the Trump Administration and the reinvigorated Republican majorities on Capitol Hill seem likely to continue.
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